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FDA Approves CAR T Cell Therapy for Non-Hodgkin Lymphoma

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By
Matthew TontonozThursday, October 19, 2017

Memorial Sloan Kettering medical oncologist Paul Hamlin treats people with lymphoma, including those with diffuse large B cell lymphoma.

Summary

People with an aggressive form of lymphoma that is no longer responding to chemotherapy may now be eligible to receive a novel cell-based immunotherapy called CAR T. Previously, this treatment was available only to people participating in clinical trials.

For the second time in recent months, the US Food and Drug Administration has green-lighted a novel form of immunotherapy, called CAR T cell therapy, for the treatment of cancer. The approval is for axicabtagene ciloleucel (trade name Yescarta) for the treatment of people with aggressive diffuse large B cell lymphoma (DLBCL), a type of non-Hodgkin lymphoma. The cell-based product is made by Kite Pharma, which was recently acquired by Gilead Sciences.

A similar product from the drug company Novartis was approved in August for pediatric leukemia. Both cell-based treatments use genetically engineered versions of a person’s own immune cells to fight cancer. MSK researchers played a leading role in developing the technique.

DLBCL is the most common type of non-Hodgkin lymphoma, a blood cancer that primarily affects older adults. The typical treatment is chemotherapy using a combination of different drugs. This treatment may provide a cure but not always.

Previously, when a person relapsed after having therapy or stopped responding to treatment, a stem cell transplant was the only option. Now, CAR T cell therapy is a second potentially life-saving choice for people who may not be eligible for a stem cell transplant, or even for those whose disease has relapsed after having had one.

For more than three decades, there has not been a single drug approved by the FDA for people with relapsed DLBCL.

Anas Younesmedical oncologist

“For more than three decades, there has not been a single drug approved by the FDA for people with relapsed DLBCL,” says Anas Younes, Chief of the Lymphoma Service at MSK. “The approval of axicabtagene is a major step forward, providing a new effective treatment option for these patients. Our group is at the forefront of developing second-generation CAR T cells to further improve their efficacy.”

The FDA based its approval of axicabtagene ciloleucel on a clinical trial, led by Kite. The trial found that nearly half of people with this aggressive type of chemotherapy-resistant DLBCL had a complete response after receiving one infusion of CAR T cells, meaning all signs of their disease disappeared (at least for a time).

To make the cell product, doctors collect T cells from a person’s blood. The cells are frozen and then shipped to a lab where they are genetically engineered to contain a new gene. The modified cells are grown in the lab until there are billions of copies and then shipped back to the hospital for reinfusion into the person’s blood through an IV days later.

As in the previously approved Novartis product, Kite’s CAR T cells target a protein on B cells called CD19. Both normal B cells and cancer cells contain CD19. Due to the action of the drug, the body temporarily loses its B cells, which are responsible for making protective immune molecules called antibodies. So people receiving CD19 CAR T therapy need to receive replacement antibodies. Some people may also experience a dangerous side effect called cytokine release syndrome, caused when the modified immune cells go into overdrive and produce chemicals that lower blood pressure and promote fever.

MSK is one of only a handful of cancer centers that have the experience and expertise necessary to administer CAR T cell therapies safely to patients.

“We have a multidisciplinary team of experts with vast experience who consult on every case,” says Sergio Giralt, Chief of the Adult Bone Marrow Transplant Service at MSK. “Our primary job is making sure that each patient gets the very best care — whether that’s CAR T cell therapy or another approach.”

Dear James, the drug that was recently approved for lymphoma is made by Kite Pharma, which was recently acquired by Gilead Sciences. The version of this treatment that’s approved for leukemia is made by Novartis. Thank you for your comment.

Dear William, there are currently no CAR T cell therapies that are approved for the treatment of prostate cancer, but this is an active area of research. There is currently another type of immunotherapy that is FDA approved for prostate cancer, the vaccine called sipuleucel-T (Provenge). Thank you for your comment.

Alex Shaykis

Oct 31, 2017 • 6:50 PM

I am a patient with multiple myeloma, one year post autologous stem cell transplant. I'm wondering if this approach would work for myeloma to maintain remission

Dear William, the company that makes this drug (Kite Pharma, which was recently acquired by Gilead Sciences) is working with a number of hospitals to offer the treatment. We recommend you contact the company to find out whether any VA hospitals will be included. Thank you for your comment.

Steven U. Leitner

Nov 1, 2017 • 9:55 AM

I have been treated for marginal B Cell lymphoma. I took chemotherapy of rituximab and bendomustine. That was 5 years ago and now my lymphoma is coming back. Can you treat me? Call me at 212-6275871 or .

Bill Dluzniewski

Nov 1, 2017 • 12:35 PM

why does one have to be subjected to chemo before this is tried ? If it is so effective, why not use it up front ?

Dear Bill, chemotherapy is still considered the “first-line” treatment for diffuse large B cell lymphoma. If it is effective, patients don’t need to the get the CAR T treatment. Even when patients do receive CAR T, they are first given what is called conditioning chemotherapy to help their blood “make room” for the new engineered T cells. Thank you for your comment.

DAHER SHAHEM

Nov 5, 2017 • 8:03 PM

I was diagnosed with stomach CA( signed ring cell carcinoma, since march 2017 , I am under chemotherapy with taxol and Ramucirumab, I was stable andit control tumor to metastasize
now mount sini oncology dept. ask me to sign of trail of immunotherapy if my PDL positive, because I am smoker, despite my cancer is stable microcell, which is not respond to immunotherapy
should I go for this trail which is required to stop my standard chemotherapy during this period
what is you advice and recommendation
thank you

Dear Daher, we’re sorry to hear about your diagnosis. Unfortunately we are not able to offer medical advice on our blog. If you would like to make a consultation for a second opinion at MSK, you can call 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment for more information on making an appointment. Thank you for your comment, and best wishes to you.

Patricia Reed

Nov 22, 2017 • 12:26 PM

Can CAR T cell therapy be used to treat those with Classical Hodgkin Lymphoma where a stem cell transplant has failed?

My mother passed away from this at 69. She developed a blood infection after her third round of CHOP and almost died then. Imaging showed the CHOP was not effective at this point and it was discontinued. She passed away 10 weeks later. I don't know if she could have survived the chemo even if it had shown to be effective. I am curious if this treatment could be used as a first line treatment in cases where chemo is too toxic for the patient?

Dear Anne, we are very sorry for your loss. Currently CAR T therapy for NHL is approved only for people whose other treatment has failed. This means it is given after chemotherapy. Thank you for your comment, and best wishes to you.

My husband has NHL/double hit and is currently undergoing chemotherapy. He has failed the EPOCH and is on RICE. We are discussing options going forward including stem cell transplant and car-t cell. If we have stem cell transplant and it fails or have a relapse can we still opt for car T cell. ? We have been told that we should have car T cell first and after remission opt for stem cell transplant

Dear Colleen, we’re sorry to hear about your husband’s diagnosis. We recommend that you discuss his treatment options with his healthcare team. If he would like to come to MSK for treatment or a second opinion, you can call 800-525-2225 or go to https://www.mskcc.org/experience/become-patient/appointment for more information on making an appointment. Thank you for your comment, and best wishes to both of you.

Stephen McClure

Mar 29, 2018 • 2:09 AM

Hi. I’m from Australia with B cell lymphoma. Rchop worked for a few months at best. Trial drug BGB3111 worked for a few months. Zydalig worked for a few months. I currently and trying to get into a period of reponse and then Bone marrow transplant. We have just started CAR-T therapy at Westmead Hospital however I was told that you must have a BMT first. From my research this does not appear to be the case.

Dear Stephen, we’re sorry to hear about your diagnosis. We recommend that you discuss this with your doctor. There are different protocols for how CAR T may be offered, depending on whether you are in a clinical trial, and which one.

Thank you for your comment, and best wishes to you.

Bob Hillerud

May 17, 2018 • 1:41 PM

My wife has Diffuse Large B Cell Lymphoma stage 4 with Lymphomatous Meningitis. If the R-CHOP Treatments and intrathecal chemo don't work would she be a good candidate for CAR T Cell therapy? Thank you.

Dx'd with Waldenstrom's Macroglobulinemia in late 2014. Two (out of 4 planned) doses of Rituxan dropped me into remission, but also very nearly killed me. 4 years later I am on Bendamustine with one more 2 day course to go. Numbers are down somewhat, but not very impressively.
I understand that WM is very rare, but is there really no research--or clinical trials--on it anywhere??? Do you know of any?
Thank you.

Dear Jeanne, we’re sorry to hear about your diagnosis. CAR T is not currently FDA approved for Burkitt’s lymphoma. If you are interested in learning what treatments MSK offers for this type of cancer, you can make an appointment online or call 800-525-2225. Thank you for your comment and best wishes to you.

Wendy Fogelstrom

Jul 31, 2019 • 1:07 PM

My mother is 80 yrs old and has refractory DLBCL are there age restrictions for Car T cell therapy.

Dear Wendy, we’re sorry to hear about your mother’s diagnosis. There are restrictions on this therapy related to other health conditions. Some of them tend to be common in older people. We recommend you discuss this with your mother’s care team. If you are interested in arranging a consultation at MSK or learning what other treatments we offer for this type of cancer, you can make an appointment online or call 800-525-2225. Thank you for your comment and best wishes to both of you.